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    Summary
    EudraCT Number:2012-000142-35
    Sponsor's Protocol Code Number:UC-0160/1105
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Restarted
    Date on which this record was first entered in the EudraCT database:2014-04-10
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedIreland - HPRA
    A.2EudraCT number2012-000142-35
    A.3Full title of the trial
    A prospective randomised phase III study of androgen deprivation therapy with or without Docetaxel with or without local radiotherapy with or without abiraterone acetate and prednisone in patient with metastatic hormone-naïve prostate cancer.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    _
    A.4.1Sponsor's protocol code numberUC-0160/1105
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUNICANCER
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportJANSSEN-CILAG
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUNICANCER
    B.5.2Functional name of contact pointIsabelle RIEGER, Project Leader
    B.5.3 Address:
    B.5.3.1Street Address101, rue de Tolbiac
    B.5.3.2Town/ cityParis cedex 13
    B.5.3.3Post code75654
    B.5.3.4CountryFrance
    B.5.4Telephone number33180 50 15 99
    B.5.5Fax number33185.34.33.79
    B.5.6E-maili-rieger@unicancer.fr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Abiraterone Acetate
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNABIRATERONE ACETATE
    D.3.9.1CAS number 154229-18-2
    D.3.9.4EV Substance CodeSUB31647
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    metastatic hormone-naïve prostate cancer
    E.1.1.1Medical condition in easily understood language
    prostate cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10036909
    E.1.2Term Prostate cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of abiraterone acetate and prednisone in patients with metastatic hormone-naïve prostate cancer treated by androgen deprivation therapy and docetaxel (with or without local radiotherapy) in terms of overall survival (OS) and radiographic progression-free survival (rPFS).
    E.2.2Secondary objectives of the trial
    • Castration resistance-free survival (CRFS)
    • Serious Genitourinary event-free survival (S-GU-EFS)
    • Prostate cancer specific survival
    • Time to next skeletal-related event
    • PSA response rate
    • Prospective correlative study of PSA response/progression at 8 months after initiation of ADT
    • Time to pain progression
    • Time to chemotherapy for CRPC
    • Quality of life
    • Toxicity (with a specific focus on the use of long-term low-dose steroids)
    • Changes in bone mineral density (BMD)
    • Correlation of biomarkers with outcome, including the prognostic and predictive value on OS, rPFS and CRFS of a neuro-endocrine differentiation of the prostate cancer in the pathological specimen
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Biologic ancillary study: constitution of a collection

    Imaging ancillary study
    E.3Principal inclusion criteria
    1. Histologically or cytologically confirmed adenocarcinoma of the
    prostate,
    2. Metastatic disease documented by a positive bone scan (any technique) and CTscan or MRI. For patients with nodal metastases only,
    only patients with extra-pelvic enlarged lymph nodes (pelvic lymph
    nodes located below the iliac bifurcation) can be included if they have
    either:
    o At least one extra-pelvic lymph node ≥ 2 cm
    or
    o extra-pelvic lymph node (s) ≥ 1 cm if the patients also have at least
    one pelvic lymph node ≥ 2 cm
    3. Patients with ECOG ≤ 1 (patient with PS 2 due to bone pain can be
    accrued in the trial),
    4. Life expectancy of at least 6 months,
    5. Male aged ≥ 18 years old, and ≤80 years old
    6. Hematology values:
    • Hemoglobin ≥ 10.0 g/dL,
    • Platelet count ≥ 100,000/mL,
    • Neutrophil ≥ 1500 cells/mm3
    7. Biochemistry values:
    • Renal function: Serum creatinine < 1.5 x ULN or a calculated
    creatinine clearance ≥ 60 mL/min,
    • Serum potassium ≥ 4 mmol/L,
    • Liver function:
    - Serum bilirubin ≤ 1.5 x ULN (except for patients with documented
    Gilbert's disease),
    - AST and ALT ≤ 1.5 x ULN (and ≤ 5 ULN in case of liver metastases),
    • ALK-P ≤ 2.5 x ULN (in case of bone metastasis, ALK-P<1000U/L if
    bilirubin is normal)
    8. Patients must have received ADT for a maximum of 3 months before
    randomization and there must be a delay of minimum 6 weeks between
    the start of ADT and the start of Docetaxel,
    9. Patients willing to receive Docetaxel,
    10. Patients might have received previous radiation therapy directed to
    bone lesions,
    11. Patients able to take oral medication,
    12. Patients who have received the information sheet and signed the
    informed consent form,
    13. Male patients who will receive Docetaxel and/or Abiraterone acetate
    and have partners of childbearing potential and/or pregnant partners
    must use a method of birth control in addition to an adequate barrier
    protection (condoms) as determined to be acceptable by the study
    doctor during the treatment period and for 4 weeks after the last dose of
    abiraterone acetate and/or for 6 months after the last dose of Docetaxel,
    14. Patients must be willing and able to comply with scheduled visits,
    treatment plan, laboratory tests and other study procedures,
    15. Patients with a public or a private health insurance coverage,
    according to local laws for participation in clinical trials.
    E.4Principal exclusion criteria
    1. Patients with previous definitive local treatment directed to the
    prostate primary cancer (radiotherapy, brachytherapy, radical
    prostatectomy, ultrasound, cryotherapy, or other). A previous transurethral
    resection of the prostate (TURP) and previous local treatments
    of metastase are allowed,
    2. Prior cytotoxic chemotherapy or biological therapy for the treatment
    of CRPC,
    3. Any chronic medical condition requiring a higher dose of
    corticosteroid than 5mg prednisone/prednisolone twice daily,
    4. Active infection or other medical condition for which
    prednisone/prednisolone (corticosteroid) use would be contraindicated,
    5. Previously treated with ketoconazole for prostate cancer for more
    than 7 days,
    6. Prior systemic treatment with an azole drug (e.g. fluconazole,
    itraconazole) within 4 weeks of randomization,
    7. Hypertension not controlled by an anti-hypertensive treatment not
    modified for more than 3 months (systolic BP ≥ 160 mmHg or diastolic
    BP ≥ 95 mmHg; 3 consecutive measures taken 5 minutes apart),
    8. Severe or moderate hepatic impairment (Child – Pugh class C or B)
    9. Active or symptomatic viral hepatitis or chronic liver disease (except
    Gilbert's disease),
    10. History of pituitary or adrenal dysfunction,
    11. Clinically known significant heart disease in the past 6 months as evidenced by myocardialinfarction, or arterial thrombotic events , severe or
    unstable angina, or New York Heart association (NYHA) Class II-IV heart
    disease or cardiac ejection fraction measurement of < 50% at baseline,
    12. Atrial Fibrillation, or other cardiac arrhythmia requiring therapy,
    13. Patient with unstable pulmonary disease (eg. Pulmonary embolism)
    14. Pathological finding consistent with small cell carcinoma of the
    prostate,
    15. History of malignancy, except non-melanoma skin cancer, with a ≥
    30% probability of recurrence within 24 months,
    16. Known allergies, hypersensitivity or intolerance to the study drugs or
    excipients,or docetaxel,
    17. Administration of an investigational therapeutic within 30 days of
    randomization,
    18. Patients already included in another therapeutic trial involving an
    experimental drug, (patient in a non-experimental trial with no
    modification of the patient's care can be included),
    19. Patients with significantly altered mental status prohibiting the
    understanding of the study or with psychological, familial, sociological or
    geographical condition potentially hampering compliance with the study
    protocol and follow-up schedule or any condition which, in the opinion of
    the investigator, would preclude participation in this trial. Those
    conditions should be discussed with the patient before registration in the
    trial,
    20. Individual deprived of liberty or placed under the authority of a
    tutor.
    21. Patients with impaired vision should undergo a prompt and complete
    ophtalmologic examination. Patients with Cystoid Macular Oeadema
    cannot be included due to a potential risk of deterioration associated
    with docetaxel.
    22. Concomitant use of strong CYP3A4 inhibitors ( clarithromyin,
    indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin.)
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints of this study are overall survival (OS) and radiographic progression-free survival (rPFS).
    Overall survival (OS) is defined as the time from randomization to the time of death from any cause and radiographic progression-free survival (rPFS) defined as the time from randomization to the radiographic progression or death.
    Radiographic progression is defined according to an adapted version of Prostate Cancer Working Group 2 (PCWG2) criteria (either a RECIST progression in case of measurable lesions or the appearance of at least 2 new lesions on bone scan). In contrast to PCWG2 criteria, a second bone scan is not mandatory to confirm radiographic progression. The date of radiographic progression will be the date of progression as per the above definition.
    It should be noted that a patient can enter the post-CRPC follow up if progressive disease has been established by a PSA rise only, without radiographic progressive disease. In this scenario, imaging monitoring will continue every 6 months and radiographic progression may be established later.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Not applicable
    E.5.2Secondary end point(s)
    • Castration resistance free survival (CRFS) is defined as the time from randomization to the castrate-resistant (CRPC) status or death from any cause.
    CRPC is defined by cancer progression (either a confirmed PSA rise or a radiographic progression) with serum testosterone being at castrated levels (<0.50 ng/mL).
    A PSA rise is defined by an increased serum PSA on 2 different measurements, confirmed by a third measurement (measurement A<B<C). The minimum level of the third PSA measurement should be 0.5 ng/mL.
    A minimum delay of 2 weeks is recommended between measurements A and B. A delay of 3 months is recommended between measurement B and C. The date of progression will be the date of measurement C.
    Serum testosterone should be obtained when PSA measurement C is done.
    In case of progression while serum testosterone is > 0.50 ng/mL, the patient should be rapidly submitted to another method of castration (chemical or surgical) and PSA + testosterone should be tested again to confirm or not CRPC progression.
    Radiographic progression is defined as per the above definition.
    For patients alive without radiographic progression or confirmed PSA rise at the time of analysis, data will be censored at the date of last follow-up.
    • Serious Genitourinary event-free survival (S-GU-EFS) is defined as the time from randomization to the first occurrence of one of the following events : urinary retention with need for a urinary catheter, suprapubic catheter, double J stent, nephrostomy, treatment of the prostate by radiotherapy (except that by randomization in arms C and D) or trans-urethral resection of the prostate (TURP), prostatectomy or death. It is assumed that prostate radiotherapy (and abiraterone) may prevent or delay these serious genitourinary events. For patients alive without Serious Genitourinary Event at the time of analysis, data will be censored at the date of last follow-up.
    • The prostate cancer-specific survival will be calculated from the date of randomization to the date of the death due to prostate cancer. For patients alive at the time of analysis, or who died from a cause other than prostate cancer, data will be censored at the date of last follow-up,
    • The time to next skeletal-related event will be defined by either a fracture or a bone pain requiring radiation therapy or a spinal cord compression or a preventive surgery to the bones. Events will be evaluated by investigators. No systematic X-Ray will be perform
    • PSA response rate will be assessed using a waterfall plot. Complete PSA response is defined by an undetectable serum PSA level (<0.2 ng/mL).
    • The prospective correlative study of PSA response/progression will be evaluate at 8 months after initiation of ADT,
    • The time to pain progression will be evaluated by questionnaires (BPI-SF) and calculated from the date of randomization to the first date the patient experiences a BPI-SF increase by ≥ 30% from baseline in the BPI-SF worst pain intensity (items 3) observed at 2 consecutive evaluations ≥ 4 weeks apart.
    • The time to chemotherapy will be calculated from the date of randomization to the date of the first use of chemotherapy treatment for CRPC
    • Quality of life will be evaluated using the FACT-P and QLQ-C30 questionnaires.
    • Toxicity (with a specific focus on the use of long-term low-dose steroids) will be evaluated according to NCI-CTCAE v4.0
    • Bone loss will be evaluated by bone mineral density (BMD) to determine if patients receiving Abiraterone acetate and prednisone and/or radiotherapy have an increase risk
    • Correlation of biomarkers with outcome, including the prognostic and predictive value on OS, rPFS and CRFS of a neuro-endocrine differentiation of the prostate cancer in the pathological specimen.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    androgen deprivation therapy with or without local radiotherapy with or without abiraterone acetate
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA90
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years10
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years10
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 584
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 584
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1168
    F.4.2.2In the whole clinical trial 1168
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-06-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-17
    P. End of Trial
    P.End of Trial StatusRestarted
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